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Treatment of Lower Extremity Spider Veins With Excel V

Primary Purpose

Telangiectasis, Spider Veins

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Sponsored by
Cutera Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telangiectasis focused on measuring Telangiectasis, Spider Veins, Excel V, Cutera, Laser, Leg Veins, Venulectasia, Lower Extremity veins, Laser light, KTP, 532nm

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fitzpatrick Skin Type I - III
  • Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins
  • Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator
  • Having lower extremity spider veins appropriate for laser treatment, as assessed by the Investigator
  • Subject must be able to read, understand and sign the Informed Consent Form
  • Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
  • Wiling to have limited sun exposure for the duration of the study, including the follow-up period
  • Willingness to have digital photographs taken of lower extremity spider veins
  • Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study
  • Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments
  • For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study

Exclusion Criteria:

  • Having received any prior laser treatment for lower extremity spider veins
  • Fitzpatrick Skin Type IV - VI
  • Pregnant
  • Having an infection, dermatitis or a rash in the treatment area
  • Having significant varicosities or perforator veins
  • History of keloid scarring, hypertrophic scarring or of abnormal wound healing
  • History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
  • History of connective tissue disease, such as systemic lupus erythematosus or scleroderma
  • History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
  • Having a known anticoagulative condition or taking anticoagulation medications
  • History of thromboembolic disease, such as deep vein thrombosis (DVT)
  • History of seizure disorders due to light
  • Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen
  • Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
  • Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy
  • Undergoing systemic chemotherapy for the treatment of cancer
  • Systemic use of isotretinoin (Accutane®) within 6 months of study participation
  • Any use of gold therapy for disorders such as rheumatologic disease or lupus
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
  • Participation in a study of another device or drug within three months prior to enrollment or during the study
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Sites / Locations

  • Main Line Center for Laser Surgery

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

532 nm KTP Laser Treatment

Arm Description

Outcomes

Primary Outcome Measures

Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)

Secondary Outcome Measures

Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: 1 = Very Much Not Satisfied 2 = Not Satisfied 3 = Somewhat Satisfied 4 = Satisfied 5 = Very Much Satisfied
Mean Pain Score Associated With Laser Treatment.
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Mean Pain Score Associated With Laser Treatment
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).

Full Information

First Posted
May 25, 2011
Last Updated
January 26, 2015
Sponsor
Cutera Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01362192
Brief Title
Treatment of Lower Extremity Spider Veins With Excel V
Official Title
A Clinical Evaluation of the Treatment of Lower Extremity Spider Veins Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.
Detailed Description
Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins in at least 2, and up to 4, separate areas. Subjects will receive 2 laser treatments spaced 12 weeks apart. Subjects will be followed for 24 weeks (12 weeks after the final laser treatment). Efficacy will be evaluated by blinded independent physician assessment of improvement in treated spider veins using digital photographs taken at baseline and the final follow-up visit by a third-party medical photography service. In addition, efficacy will be evaluated by the Investigator's mean global assessment of improvement and the subject's mean assessment of improvement. Safety will be evaluated by continuous monitoring of adverse events (AEs) and measuring pain associated with laser treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasis, Spider Veins
Keywords
Telangiectasis, Spider Veins, Excel V, Cutera, Laser, Leg Veins, Venulectasia, Lower Extremity veins, Laser light, KTP, 532nm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
532 nm KTP Laser Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Other Intervention Name(s)
Excel V laser, ExcelV, KTP, 532nm
Intervention Description
The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows: Spot Size: 5 mm Fluence: 13-15 J/cm2 Pulse Duration: 40 ms Epidermal contact-cooling: 5° Celsius
Primary Outcome Measure Information:
Title
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
Description
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame
24 weeks (12 weeks post-final laser treatment)
Secondary Outcome Measure Information:
Title
Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments
Description
The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame
12 weeks (post-1st laser treatment)
Title
Percent of Subjects With "Significant" or "Very Significant" Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator.
Description
The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame
24 weeks (12 weeks post-final laser treatment)
Title
Percent of Subjects With "Significant" to "Very Significant" Improvement of Lower Extremity Spider Veins, as Assessed by Subject.
Description
Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale: 0 = No Improvement (0%) 1 = Mild Improvement (< 25%) 2 = Moderate Improvement (26 to 50%) 3 = Significant Improvement (51 to 75%) 4 = Very Significant Improvement (76 to 100%)
Time Frame
24 weeks (12 weeks post-final laser treatment)
Title
Percent of Subjects Satisfied With Improvement of Treated Spider Veins.
Description
Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale: 1 = Very Much Not Satisfied 2 = Not Satisfied 3 = Somewhat Satisfied 4 = Satisfied 5 = Very Much Satisfied
Time Frame
24 weeks (12 weeks post-final laser treatment)
Title
Mean Pain Score Associated With Laser Treatment.
Description
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time Frame
Day 0 (1st laser treatment)
Title
Mean Pain Score Associated With Laser Treatment
Description
Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).
Time Frame
12 weeks (2nd laser treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fitzpatrick Skin Type I - III Having at least 2 separate areas measuring 5cm x 5cm of lower extremity spider veins Having lower extremity spider veins less than 2.0mm in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the Investigator Having lower extremity spider veins appropriate for laser treatment, as assessed by the Investigator Subject must be able to read, understand and sign the Informed Consent Form Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions Wiling to have limited sun exposure for the duration of the study, including the follow-up period Willingness to have digital photographs taken of lower extremity spider veins Agree not to undergo any other procedure for the treatment of lower extremity spider veins during the study Willing to not take any 'prn' medications for aches and pains (such as Tylenol® or Advil®) on the days of the laser treatments For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study Exclusion Criteria: Having received any prior laser treatment for lower extremity spider veins Fitzpatrick Skin Type IV - VI Pregnant Having an infection, dermatitis or a rash in the treatment area Having significant varicosities or perforator veins History of keloid scarring, hypertrophic scarring or of abnormal wound healing History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications History of connective tissue disease, such as systemic lupus erythematosus or scleroderma History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation Having a known anticoagulative condition or taking anticoagulation medications History of thromboembolic disease, such as deep vein thrombosis (DVT) History of seizure disorders due to light Having a history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area, unless treatment is conducted following a prophylactic regimen Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely) Suffering from significant concurrent illness, such as insulin-dependent diabetes (type I or II), peripheral vascular disease or peripheral neuropathy Undergoing systemic chemotherapy for the treatment of cancer Systemic use of isotretinoin (Accutane®) within 6 months of study participation Any use of gold therapy for disorders such as rheumatologic disease or lupus Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study Participation in a study of another device or drug within three months prior to enrollment or during the study As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Facility Information:
Facility Name
Main Line Center for Laser Surgery
City
Ardmore
State/Province
Pennsylvania
ZIP/Postal Code
19003
Country
United States

12. IPD Sharing Statement

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Treatment of Lower Extremity Spider Veins With Excel V

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